Prostate Cancer

The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.

• Age ≥ 18 years
• Karnofsky performance status ≥ 70
• Life expectancy of ≥ 12 weeks as determined by treating investigator
• Adequate laboratory parameters
• Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are permitted.
• Radiographic evidence of metastatic disease
• Evidence of disease progression on androgen deprivation therapy (ADT)
• A minimum of 4 weeks from prior abiraterone acetate, sipuleucel-T, MDV3100, TAK700, ketoconazole, or other experimental anti-cancer therapies prior to registration is required.
• At least one prior systemic chemotherapy regimen FDA approved for metastatic prostate cancer.

• Patients who have received prior treatment with a PI3K inhibitor.
• Patients with a known hypersensitivity to BKM120 or to its excipients.
• Patients with untreated brain metastases.
• Patients with any of the following mood disorders as judged by the investigator or a psychiatrist
  • Severe anxiety disorder
  • Depression
  • Bipolar disorder
  • History of, or current suicidal ideation or suicide attempt
  • History of, or current, homicidal ideation or attempt
  • History of, or current, psychosis
  • History of treatment in an inpatient psychiatric setting
• Concurrent severe and/or uncontrolled cardiac conditions which could compromise participation in the study
• Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.